Return

Risk of Ovarian Malignancy Algorithm (ROMA)

Code:10006

Synonyms
Расчетный алгоритм ROMAРасчетный алгоритм риска рака яичникаOvarian cancer risk algorithmRisk of Ovarian Malignancy AlgorithmRisk of Ovarian Malignancy Algorithm (ROMA)ROMA algorithmROMA index
IncludesCA 125 HE4 ROMA index (%)

Analysis details

Methodology

  • Electrochemiluminescence immunoassay (ECLIA)
  • Risk of Ovarian Malignancy Algorithm (ROMA)

Expected Turnaround Time

1 day

Special Instructions

  • Do not smoke for at least 30 minutes before the blood draw.
  • Discontinue high-dose biotin (vitamin B7) supplements for at least 72 hours before specimen collection.
  • For serial measurements, use the same assay method each time; do not compare results obtained by different methods.

How to use

The Risk of Ovarian Malignancy Algorithm (ROMA), also known as the ROMA index or ROMA algorithm, stratifies women with a documented adnexal or pelvic mass into high- and low-risk groups for epithelial ovarian cancer by combining CA 125 and HE4 results with menopausal status. The risk estimate can inform referral to gynecologic oncology and assist in preoperative planning. ROMA is not intended for population screening and is not used to evaluate non-epithelial ovarian neoplasms.

Limitations

ROMA is a probabilistic model that incorporates serum concentrations of CA 125 and HE4 together with menopausal status to estimate the likelihood of epithelial ovarian malignancy. CA 125, a circulating glycoprotein, is commonly elevated in advanced epithelial ovarian cancer but has limited sensitivity in early-stage disease. HE4, a secreted protease inhibitor overexpressed in epithelial ovarian cancer, provides additional discrimination beyond CA 125 alone. Across validation cohorts of women with adnexal masses, the ROMA index typically demonstrates high sensitivity with moderate specificity for identifying epithelial ovarian cancer and performs favorably relative to the Risk of Malignancy Index (RMI). The algorithm applies only to epithelial ovarian tumors and does not assess risk for germ cell or sex cord–stromal neoplasms. ROMA is intended for risk stratification in patients with a confirmed pelvic or adnexal mass and should be interpreted alongside the clinical evaluation, imaging findings, and other laboratory data.

Reference interval
ParameterMaleFemale
Индекс ROMA (СА 125, HE4)0–29.9
СА 125 (онкомаркер рака яичников)0–35
HE4 (эпителиальный рак яичников)0–140
IndicationsTriage and risk categorization of women with an adnexal or pelvic mass identified on physical examination or imaging

Possible Causes of Abnormal Results

Decreased levels

  • biotin

Specimen Requirements

SpecimenSerum
ContainerGold/Tiger Top (SST, Gel Separator)
Volume1 mL (min 0.7 mL)
Storage InstructionsRoom temperature, Refrigerated, Frozen

References

Moore RG, Miller MC, Disilvestro P, Landrum LM, Gajewski W, Ball JJ, Skates SJ. Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass. Obstet Gynecol. 2011 Aug;118(2 Pt 1):280-8.

Van Gorp T, Cadron I, Despierre E, Daemen A, Leunen K, Amant F, Timmerman D, De Moor B, Vergote I. HE4 and CA125 as a diagnostic test in ovarian cancer: prospective validation of the Risk of Ovarian Malignancy Algorithm. Br J Cancer. 2011 Mar 1;104(5):863-70. doi: 10.1038/sj.bjc.6606092. Epub 2011 Feb 8.